<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20161216031432N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-02</date_registration>
      <primary_sponsor>No sponser</primary_sponsor>
      <public_title>Laser in periodontitis treatment</public_title>
      <acronym></acronym>
      <scientific_title>Study of the clinical and microbiologic effects of 940 nm Diode laser as an adjunct to scaling and root planing in treatment of Chronic periodontitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>22</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24725</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization of subjects with random number table, Blinding description: Single blind; participants.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic periodontitis.</hc_freetext>
      <i_freetext>Intervention 1: The control group: The treatment consists of scaling with an ultrasonic device and oral hygiene instructions, including how to brush correctly and use dental floss. Intervention 2: The intervention group: Scaling will be carried out with the use of an ultrasonic device in association with oral hygiene instructions, including correct brushing and use of dental floss. One week after scaling and root planing, 940-nm diode laser beams w.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data after removal of private information will release via article publication.

When:
6 months after publication.

To whom:
Students and professors

Conditions:
By written consent of investigators.

Where to obtain:
Dr. Zohri

How to obtain:
email online application of the assay.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Zohri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahed University, Persian gulf highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3319118651</zip>
        <telephone>+98 21 8895 9210</telephone>
        <email>z.zohri@shahed.ac.ir</email>
        <affiliation>School of Dentistry of Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Zohri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>N71, Italia Str, Vesal Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3319118651</zip>
        <telephone>+98 21 8895 9210</telephone>
        <email>z.zohri@shahed.ac.ir</email>
        <affiliation>School of Dentistry of Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Moderate to severe chronic generalized periodontitis, presence of one pocket
measuring 4‒6 mm in depth and bleeding on probing in all the 4 quadrants
Systemic health</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Presence of radicular infection or active caries
Systemic diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K05.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic pericoronitis Periodontitis: NOS complex simplex</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The control group: The treatment consists of scaling with an ultrasonic device and oral hygiene instructions, including how to brush correctly and use dental floss.</i_keyword>
      <i_keyword>The intervention group: Scaling will be carried out with the use of an ultrasonic device in association with oral hygiene instructions, including correct brushing and use of dental floss. One week after scaling and root planing, 940-nm diode laser beams w</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pocket Probing Depth. Timepoint: before treatment,1 month and 3 month after treatment. Method of measurement: The distance between the gingival margin and the pocket base, which will be measured at 6 points of each tooth (mesiobuccal, buccal, distobuccal, distolingual, lingual and mesiolingual) with the use of a Williams graduated probe. The mean probing depth at each site will be registered as the probing depth in that area.</prim_outcome>
      <prim_outcome>Clinical Attachment Level. Timepoint: before treatment,1 month and 3 month after treatment. Method of measurement: Williams probe.</prim_outcome>
      <prim_outcome>Gingival Level. Timepoint: before treatment,1 month and 3 month after treatment. Method of measurement: Williams probe.</prim_outcome>
      <prim_outcome>Modified Gingival Index. Timepoint: before treatment,1 month and 3 month after treatment. Method of measurement: Observation.</prim_outcome>
      <prim_outcome>Papillary Bleeding Index. Timepoint: before treatment,1 month and 3 month after treatment. Method of measurement: Periodontal probe and observation.</prim_outcome>
      <prim_outcome>Porphyromonas gingivalis. Timepoint: before treatment,1 month and 3 month after treatment. Method of measurement: Real time polymerase chain reaction.</prim_outcome>
      <prim_outcome>Tannerella forsythia. Timepoint: before treatment,1 month and 3 month after treatment. Method of measurement: Real time polymerase chain reaction.</prim_outcome>
      <prim_outcome>Treponema denticola. Timepoint: before treatment,1 month and 3 month after treatment. Method of measurement: Real time polymerase chain reaction.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>-. Timepoint: -. Method of measurement: -.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>No sponser</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-28</approval_date>
        <contact_name>Shahed University of Medical Sciences</contact_name>
        <contact_address>Shahed University,Tehran, Iran. N71, Italia Str, Vesal Ave, Tehran ,Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
